Study Subjects Currently Enrolled in a Clinical Research TrialRTDNCT05553288
Effectiveness of a Real Time Data Safety Study Tool
An observational study of Study Subjects Currently Enrolled in a Clinical Research Trial, run by Perseverance Research Center, LLC at 1 site in United States.
Trial summary
Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Study Subjects Currently Enrolled in a Clinical Research Trial
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 5 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: -Men and women from 18-85 years of age inclusive, who are currently enrolled in a clinical trial at Perseverance Research Center. All subjects must meet all inclusion and no exclusion criteria to be eligible for enrollment.
Who may be able to join
- 18-85 age inclusive
- Male or Female
- Currently enrolled in an ongoing clinical trial
- Capable of providing informed consent and complying with daily study procedures
- Must be able to receive and respond to text messages through phone provider
Who cannot join
- Subjects not currently involved in a clinical trial
- Subjects who cannot receive text messages
- Unable to comply to the study protocol and study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Perseverance Research Center, LLC
Scottsdale, Arizona, 85254
About this study
Official title: Determining the Effectiveness of a Real Time Data Safety Study Tool for Clinical Research Subjects
Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials.
Read the detailed description
This study is to determine if a daily SMS text message study tool will improve adverse event and concomitant medication reporting. Patient reported adverse events and changes in concomitant medications are essential in clinical trials to determine drug-related symptoms and side effects. This study will help identify the benefits and challenges of real time daily reported outcome measures that can later be implemented in future clinical trials to enhance trial outcomes. In addition, data collected from this study will support a more sophisticated safety study tool for future study participants.
- Keywords
- text messaging, safety, real time data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| active group | Every study participant will actively receive daily text messages asking about their change in health and concomitant medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To improve AE and concomitant medication reporting
Data collected daily through secure text messaging
Measured: 6 weeks
Secondary outcomes (1)
Decrease recall bias
Daily reporting of AEs and concomitant medication changes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Aug 2022
- Primary completion28 Oct 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study Subjects Currently Enrolled in a Clinical Research TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perseverance Research Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- HDC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553288
- Sponsor's protocol ID
- RTD-01
- Acronym
- RTD
- Status last verified
- Nov 2022
- First submitted
- 20 Sep 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of a Real Time Data Safety Study Tool for Clinical Research Subjects
- ClinicalTrials.gov ID
- NCT05553288
- Acronym / sponsor ID
- RTD / RTD-01
- Keywords
- text messaging, safety, real time data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Perseverance Research Center, LLCUniversity, hospital or other
- Collaborators
- HDC
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study RTD-01 is a non-interventional, pilot study designed to determine if a specific coded SMS text message study tool is effective in collecting daily real time safety data in subjects participating in clinical trials.
Detailed description
This study is to determine if a daily SMS text message study tool will improve adverse event and concomitant medication reporting. Patient reported adverse events and changes in concomitant medications are essential in clinical trials to determine drug-related symptoms and side effects. This study will help identify the benefits and challenges of real time daily reported outcome measures that can later be implemented in future clinical trials to enhance trial outcomes. In addition, data collected from this study will support a more sophisticated safety study tool for future study participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active group | – | –Every study participant will actively receive daily text messages asking about their change in health and concomitant medication. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -Men and women from 18-85 years of age inclusive, who are currently enrolled in a clinical trial at Perseverance Research Center. All subjects must meet all inclusion and no exclusion criteria to be eligible for enrollment.
Key inclusion criteria (5 listed)
- 18-85 age inclusive
- Male or Female
- Currently enrolled in an ongoing clinical trial
- Capable of providing informed consent and complying with daily study procedures
- Must be able to receive and respond to text messages through phone provider
Key exclusion criteria (3 listed)
- Subjects not currently involved in a clinical trial
- Subjects who cannot receive text messages
- Unable to comply to the study protocol and study visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To improve AE and concomitant medication reporting
Time frame: 6 weeks
Data collected daily through secure text messaging
1 secondary outcome
Decrease recall bias
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Study Subjects Currently Enrolled in a Clinical Research Trial, run by Perseverance Research Center, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To improve AE and concomitant medication reporting (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.